Jenn McNary has two sons with the same fatal genetic disease, but only one has access to a potentially life-saving treatment.

Apr. 6, 2013

Written by

MELISSA PASANEN and MADDIE MCGARVEY/FREE PRESS

Jenn McNary, Austin's mother, helps Austin from his wheelchair into the pool. The swimming pool built into their house is often the only way that Austin can exercise. Austin and his brother both suffer from Duchenne Muscular Dystrophy. Austin is completely wheelchair-bound and struggles doing basic activities such as brushing his teeth and drinking out of a glass (he can no longer drink out of a glass without a straw) while his brother Max can run and jump around like a normal kid. Max is benefiting from a drug called eteplirsen through a clinical trial. Jenn fights daily to try to get Austin on the drug that could save his life, but is still in the trial stage. Austin has to watch his brother get better by the day while his disease progresses. "Our family is normal, we have good days and bad days, but one thing stays the same. Every day is a fight to save our sons lives," Jenn says. (MADDIE MCGARVEY/FREE PRESS)

The Leclaire boys share a cheerfully cluttered bedroom in their family’s modest ranch located in a rural village about 20 miles north of Brattleboro. A pair of twin beds line up against one wall and sky-blue curtains printed with planets frame the windows. Pet turtles, crabs and lizards inhabit a row of cages and stuffed animals and art projects fill corners.

The brothers have the same thatch of copper-brown hair, deep green eyes, freckled fair skin and they also share something else. Both Austin, 14, and Max, 11, have a rare genetic disease called Duchenne Muscular Dystrophy (DMD), a fatal condition characterized by progressive muscle degeneration and weakness due to lack of dystrophin, a protein that helps preserve muscle cells. There is no cure for DMD and standard treatments like steroids, heart medication and surgery only manage the symptoms. Typically, people with DMD die by their mid-20s.

There is, however, a new drug in trial that shows promise in stabilizing the disease and possibly even allowing some health improvement. The catch is that this is something the Leclaire brothers cannot share; only Max qualified for the trial, and though he has experienced significant health gains during the past 18 months, his older brother can only look on from his wheelchair as his physical condition continues to deteriorate.

Austin sits in a hospital room while Max gets his weekly treatment. "Every day that Austin doesn't have the drug, he gets worse," Jenn says. "In four or five years, he could die. It's not uncertain at all. We know what happens with boys with Duchenne. He will die." (MADDIE MCGARVEY/FREE PRESS)

Bittersweet news

Starting when they were toddlers, the Leclaire brothers experienced classic symptoms of DMD, their mom Jenn McNary, 32, explained recently sitting at her kitchen table.

DMD affects primarily boys and, according to the nonprofit Parent Project Muscular Dystrophy (PPMD), occurs in 1 out of every 4,600 to 5,600 male births worldwide. PPMD estimates that 10,000 to 12,000 individuals in the U.S. are living with DMD. By their later teens, McNary said, most people with DMD have developed serious spine issues as well as heart and lung problems, which are usually the eventual cause of death.

As preschoolers, Austin and Max both started having trouble walking and by the time Austin was 10, he was in a wheelchair full-time and has continued to lose upper body function. Like his big brother, Max was on his way to becoming wheelchair-bound. As he got older, he struggled to walk for sustained periods and fell frequently, McNary said. Then, in the summer of 2011, the siblings’ health histories diverged when Max was accepted as one of 12 subjects in a promising drug trial. His older brother did not qualify because he could not walk.

The results have far exceeded the family’s expectations.

Max Leclaire dances with his classmates at Saxtons River Elementary School during music class. Before starting the trial for the drug eteplirsen, Max had to rely on his wheelchair and motor scooter much of the time and was starting to lose his basic functions like his brother Austin. Now he can dance around with classmates and act like a normal 11 year-old boy. "This is the first treatment for Duchenne and this is first time that many families have had any hope," Jenn, his mother, says. "And it is so close." (MADDIE MCGARVEY/FREE PRESS)

While Austin can no longer lift a glass of water and must drink from a cup with a straw, Max looks much like the other energetic 4th graders playing in the Saxtons River Elementary playground or running through the woods on a late March sugaring field trip. His mother recently tweeted a photo of him energetically pushing their luggage through the airport in the wheelchair he used to depend upon for long trips.

She has also shared more sobering observations like that of her older son, Austin: “11/19/12, 4:47 PM Austin watching Max at dinner ‘now I'm the only not normal kid in the family.’”

Austin said he’s seen his brother Max rapidly transform as a result of the drug trial. "Max was slowly stopping being able to walk, and as soon as he's on the drug he's hopping around being more annoying,” he explained.

Experiencing the positive health progress for her younger son while her older son continues to steadily decline has been bittersweet; it has also led McNary in a new direction. Recognizing the strength of her family’s story, she has taken it to regional and national media; to the Internet, where more than 175,000 people have signed a petition on Change.org; and eventually to the Food and Drug Administration (FDA), which has the power to expedite approval of new drugs that fill an unmet medical need and show early promise in treating a serious disease.

Austin Leclaire sits in his wheelchair at his home in Saxtons River. Austin and his brother both suffer from Duchenne Muscular Dystrophy. Austin is completely wheelchair bound and struggles doing basic activities such as brushing his teeth and drinking out of a glass while his brother Max can run and jump around like a normal kid. Max is taking a drug called eteplirsen through a clinical trial. Austin has to watch his brother get better by the day while his disease progresses. (MADDIE MCGARVEY/FREE PRESS)

“It’s such a tragedy to split it right down the middle of the bedroom,” McNary said. “We’ve got one kid that’s getting better every day and one that’s getting worse.”

Seeing the progress in his brother, Austin dreams about how the drug might change his own life. "I would like to do the same things I have been doing but hopefully it will make things easier. I just hope (the FDA) has it in their hearts to help me."

McNary began this journey as an overwhelmed but devoted 21-year-old single mother of two boys diagnosed with a rare, fatal, genetic disease. Over the last decade, she has grown into a laser-focused, highly knowledgeable and effective advocate for her sons and for the DMD community, as well as an example of the role patients and families can play to support accelerated approval of promising new drugs.

When lightning strikes twice

McNary had her oldest son, Austin, the December after she graduated from high school in 1998. She had grown up an only child of a divorced mom, independent and smart but not fully engaged in school. “I always wanted to be a mom,” she said, “I’ve always loved children.”

McNary supported herself and her son running a registered family day care while pursuing early childhood development studies at night. She even saved enough to buy a split-level ranch in her hometown of Brattleboro. Wanting a sibling for Austin, McNary became pregnant again when he was 2 ˝. At that point, she stopped carrying her son around so much and started noticing that he was not as active as the other five children she cared for.

"Being a mother in general is not easy. You make a lot of decisions every day. Being a mother of kids with disabilities is probably ten times the amount of decisions that are very important," Jenn says. Jenn is a mother to four kids and stepmom to two, ranging from 2 to 14 years old. "My 5-year-old and my 2-year-old have had to grow up a little faster. I can't devote every bit of my day to them." (MADDIE MCGARVEY/FREE PRESS)

“I had all these other kids the same age who were starting to learn to ride a tricycle, kicking balls and running around, and I noticed that he wasn’t doing those same things,” McNary recalled. “The pediatrician said I was spoiling him, so I really tried to get him to walk more, but he just wouldn’t. I knew enough about typical child development to ask for an evaluation, but we didn’t get an appointment until after Max was born, and he was already three months old.”

Given the rarity of DMD and how long it can sometimes take to get a diagnosis, McNary said the family was lucky that the physical therapist quickly requested a blood test, which indicated DMD, later confirmed by genetic testing. At the same time, McNary’s blood showed she was not a carrier, but that the disease had been caused by a spontaneous genetic mutation in her egg. Given that scenario, her pediatrician said it was unlikely her baby son also had DMD, but McNary persisted until the doctor agreed to a blood test for Max, which also came back positive.

'Nothing you can do'

It was 10 p.m., McNary recalled, when she received the phone call. “I was sitting on the edge of the bed, holding the baby. Austin was in bed. The doctor said, ‘Please try to forget, try to ignore it. There’s no treatment for this, and I don’t need to see them until they start developing symptoms when they’re 6 or 7.’” The young mother was in shock. “I went through the worst night of my life. I didn’t have Internet. I had to wait until I could get to the library. I had no idea what this Duchenne was.”

She started doing research. “I googled Duchenne,” she said, “and I found this organization called Parent Project Muscular Dystrophy,” which she later learned had been established in 1994 by another DMD mom, Pat Furlong of Ohio, after her two sons died of the disease. Furlong had led the way gathering all available information and resources for DMD families and was very supportive, McNary recalled.

Furlong was all-too-familiar with the DMD experience within the medical system, which knew even less about the rare disease when her sons had it. The gene that causes it was not discovered until 1986, she points out, and there were no comprehensive established standards of care until 2010. “Doctors would be as kind as possible,” Furlong said over the phone from her Middletown, Ohio, office, “but therapeutic nihilism was rampant, meaning there’s no hope and there’s no help. It was, ‘Welcome to Duchenne. Your children are going to die. Your marriage is going to fall apart. Do you have any questions?’”

Through the Parent Project Muscular Dystrophy website, McNary started connecting with other DMD families and learned that some children seemed to benefit from early physical therapy, heart medications and steroid regimens. Armed with this information, she went to see the pediatric neurologist but once again, “He told me that I should take them home and love them,’” she recalled. “He said, ‘There’s nothing you can do. Nothing.’”

McNary was distraught, frustrated and reluctant to accept inaction. “Through this whole journey, there have been a lot of people who want to tell me, ‘There’s nothing you can do,’” she said. “And I don’t think that’s true. Ever. I think there’s always something you can do.”

Austin blows bubbles at his little sister Norah at Dartmouth-Hitchcock Medical Center in New Hampshire while his brother Max gets his weekly infusion. "Austin may not live five years," Jenn says. "We will lose people waiting for a drug that exists. It's unacceptable." (MADDIE MCGARVEY/FREE PRESS)

Seeking education and experts

With the help of her mother, who lived nearby, McNary was able to leave the boys when they were 6 and 3, to attend the PPMD annual conference. Based on input from other parents, she put her sons on steroids and started a search for specialists who would be more willing to consider proactive treatment.

In this goal, McNary was supported by her current pediatrician, Dr. Susan Slowinski, a partner in Cornerstone Pediatrics in Bellows Falls, who has been the boys’ primary care doctor since 2004. Slowinski said, “I don’t think Jenn always felt supported by the medical profession. She had to spend a good deal of time trying to find allies. But once she did, she works with her kids and with the system together.”

With Slowinski’s help and thanks to Vermont Medicaid supplemented by the state’s Children with Special Health Needs program, McNary was able to transfer her sons’ specialty care to Ohio, first Cincinnati and then Columbus.

McNary felt a sense of urgency as she watched her older son struggle to walk distances or to get up off the floor. She knew the same was ahead for his little brother. And so when Austin was 8 and Max was 5, she took them for their first visit to Nationwide Children’s Hospital in Columbus.

“That’s the hub,” she said.

It was both a relief and another kind of challenge for the young single mom. “I don’t think I’ve ever worried that much about the hows of things. I just knew that they needed to get there,” McNary said. Her father happened to live in Columbus, which helped, and her mother assisted initially with the cost of travel. Although the first four days of testing were overwhelming, she said, “It was really nice to meet people who knew what to do.”

Setting priorities

Craig McNary plays with Austin in the pool. "Austin sits there and sees the drug in front of his face every day and that's really hard," Craig says. "It's hard to try to explain to him that it is that way. He doesn't want to hear that there's red tape and government this and that. He doesn't care about that. He knows his brother is fine and he wants the drug too." (MADDIE MCGARVEY/FREE PRESS)

McNary continued to support herself and her sons with her home day care business supplemented with waitressing at night while her mom or stepsister watched the boys. “I was working a lot,” she said. One day, into work came Craig McNary, a recently divorced dad with joint custody of his 2-year-old twins. The two married in 2008 and added two more children, James, now 5, and toddler Norah to their family. (James does not have DMD, and Norah will be tested later to see if she is a carrier.)

As a family, getting the best care for Austin and Max has remained a top priority. Craig McNary has always been fully on board, but it takes significant resources: financial, physical and emotional. After she had James, Jenn McNary stopped running her home day care; her husband works for a family business, which affords him flexibility. Regular travel to Ohio and to various conferences and advocacy trips is expensive, but “we cut corners in other places,” she said.

Immense emotional strength is also required to ride the rollercoaster of rare disease, from the highs of promising drug developments to the lows of regular deaths within the community.

While sharing her story, Jenn McNary asked for a moment to check her phone and email and stopped short in the middle of a sentence. The 20-year-old son of a man who had offered much support and advice over the years had died just that morning. He had DMD. She shook her head. “This is the everyday stuff that can sort of stop you in your tracks. I mean these kids are dying every single day. It’s devastating. It’s so scary to watch people that you’ve known for 10 years raising their kids and watch those kids start dying.”

“You have to compartmentalize,” she continued, adding that she feels lucky to have strong support from Vermont’s health care program for children, from her family and from her husband. She sees a lot of families become consumed by sadness, financial burdens and day-to-day logistics. It comes down to being able to step back and set priorities, she said.

“If your priority is a clean house, or that your kid gets really good grades and you don’t want to pull him out of school to go for a trial drug infusion every week … I mean no amount of schooling matters if your kid has a terminal illness.”

Glimmer of hope

Austin gives his little sister Norah a ride on his power wheelchair outside of Dartmouth-Hitchcock after Max got his weekly infusion. "We try not to celebrate in this house," Jenn says. "How can we celebrate Max's gains when Austin is just losing?" (MADDIE MCGARVEY/FREE PRESS)

Jenn McNary always kept a close eye on developments in treatment options, particularly those that might address the underlying causes of DMD. Conferences, such as the annual PPMD event and others, have been critical she said, helping her connect with hundreds of other families, as well as leading physicians, researchers and drug companies working on DMD-related projects. “You get incredible direct access to people at these conferences,” she said.

It was at one such conference in 2006 that Jenn McNary met Australian researcher Steve Wilton, who was working on a promising technology called exon-skipping. At the time, it was a lot to digest, but now she easily explains it as a “molecular band-aid,” which can mask or skip some of the gene mutations and deletions that block normal dystrophin production and so allow at least some of this critical protein to be made. “He’s sitting there with a cocktail napkin diagramming the Duchenne gene and showing me where my kids need skips,” recalled Jenn McNary. Wilton cautioned her that it would be a few years until the research would be translated into a drug that might help her kids, but still he gave her hope and something to watch for.

This led her to a 2009 conference in London involving two small drug companies who were working on exon-skipping drugs that addressed the specific mutation in her sons. “I said, ‘That’s what my kids need, and I need to go figure out how to get my kids in these trials,’” Jenn McNary recalled.

In 2010, through her Facebook network of DMD parents, Jenn McNary caught wind of an exon-skipping drug trial much closer to home – in Columbus, Ohio. The trial was for kids like Austin, who were no longer walking, but it was only a safety trial which means that the dose would not be at a therapeutic level that could actually help him.

Max Leclaire gets his weekly infusion of eteplirsen at Dartmouth-Hitchcock Medical Center. Once a week he goes through an hour of IV and then an hour of observation. Usually the whole family goes for support and Austin watches Max receive the drug. "It's got to be hard [on Austin]," Jenn says. "He needs this drug more than Max does. It's hard for our whole family. But I think it's particularly hard to be in the bed next to your brother every night or going to the hospital to watch him get an infusion you desperately need. It's hard for an adult to understand why a drug exists and we can't have access to it right now, but it's even harder for a 14-year-old." (MADDIE MCGARVEY/FREE PRESS)

Austin and his mom moved to Columbus for the summer to participate in the hopes the trial would go well and advance to a therapeutic phase. They were disappointed when there was no follow-up study with non-walking patients. “It was really, really hard,” Jenn McNary said.

'Cautiously optimistic'

Again via Facebook, Jenn McNary learned of another promising drug trial, this time only for boys who were still walking like her younger son, Max. Max was accepted as one of 12 boys in a study of eteplirsen, an exon-skipping drug from Sarepta Therapeutics of Cambridge, MA.

After 82 weeks on eteplirsen, Max is running, jumping and skipping with no sign of the increasing difficulties he was demonstrating right before he started the trial, his mother said. She has been sharing his progress on Twitter. In September, she tweeted that Max “skipped down full flight of stairs, burst out doors while teachers stared in awe.” Later in the fall, she tweeted that he had previously lacked fine motor skills but was now sitting at the table teaching his younger siblings to write.

From a scientific perspective, the trial has involved three surgical biopsies to measure dystrophin and the results have been positive across the 12 trial subjects, all of whom started with zero functional dystrophin. Physicians involved in a drug trial cannot comment on results in specific patients, but Max’s most recent biopsy showed he was producing 60 percent of normal dystrophin, Jenn McNary said, among the highest in the trial.

On Friday, Sarepta released 74-week data showing "continued stabilization of walking ability" for trial participants, according to a company statement.

Dr. Richard Finkel, a pediatric neurologist who has worked in the field of DMD for 30 years and is chief of the Division of Neurology at Nemours Children’s Hospital in Orlando, Fla., is heartened by the progress with exon-skipping therapies, which he describes as “promising, although they have their challenges.” These “gene-editing treatments,” as he calls them, are not a cure, he clarified, “but they allow the body to make at least some of the functional protein (dystrophin) and early results show they might be disease-stabilizing and, in the case of eteplirsen, possibly even allow some improvement, so we can be cautiously optimistic.”

Using the megaphone

The McNarys are more than cautiously optimistic. Still, Jenn McNary admits that, as knowledgeable as they had become, they hadn’t quite thought through the next step.

“We were pretty naďve,” she said. “As soon as we knew the drug was working, we thought that it would be super-easy to just talk the company into giving Austin the drug. But it became painfully apparent very quickly that this was not going to happen for a number of reasons.”

Austin swims in the pool at his home in Saxtons River. Swimming is often the only form of exercise that Austin has during the day. "I would like to do the same things I have been doing but hopefully it will make things easier," Austin says. "I just hope [the FDA] has it in their hearts to help me." (MADDIE MCGARVEY/FREE PRESS)

The McNarys soon understood that the small drug company Sarepta was putting all of its resources toward producing the drugs needed for the trial and could not easily generate more without detracting from its overall goal of completing the approval process in the most efficient way possible. As difficult as it was to give up the idea of getting eteplirsen immediately to their older son, Jenn McNary said, “We realized we need to do whatever we can to support Sarepta instead of going after this drug company, which we want desperately to succeed.”

The focus of her effort shifted to educating the FDA about the situation, requesting that the drug receive accelerated approval and generating public support for that appeal.

“Our first floundering attempts were literally me sitting on the computer last summer posting our story on Facebook to various media,” Jenn McNary said. Vermont television stations and newspapers picked up the story, a post on a popular money-saving blog went viral, supporters started petitions, and the story came to the attention of national media, including the New York Times, the Huffington Post and Time.

“People were starting to pay attention, and I realized this was probably a story people would latch onto,” Jenn McNary said. “You don’t have to have a ton of money. Money’s not what this is going to take. You just have to have a voice.”

Jenn McNary started a Twitter account (@jennmcnary) with the tagline “fighting duchenne to save my sons … lead, follow, or get the hell outta my way!” but the tool she probably used best was Change.org, which calls itself the “world’s largest petition platform,” according to its communications manager, Megan Lubin.

A Change.org campaigner reached out to Jenn McNary after she heard her story and helped her refine a petition. In part, it reads: “Eteplirsen is the first hope we have had since Austin and Max were diagnosed with Duchenne. It has the ability to stop this disease in its tracks ... and the boys who need this drug simply don’t have one more day to waste, waiting for it. Austin does not have one more day to waste, waiting for it.”

The petition has earned more than 175,000 signatures, placing it in the top 1 percent of campaigns on the site right now, Lubin said.

Getting an audience with the FDA, however, proved harder than getting 175,000 people to sign a petition.

“I told a reporter in September that I was going to go to the FDA,” Jenn McNary said with a rueful grin. “I had no idea what that meant.”

After many dead ends, Jenn McNary finally made it onto the agenda of an FDA meeting in February after reaching out to the Virginia-based Abigail Alliance, which focuses on increasing access to developmental drugs, and has an established relationship with the FDA. At the meeting, she was able to present her Change.org petition and also share the perspective of Duchenne patients and their families on the risk/benefit of expedited drug approval for eteplirsen.

Abigail Alliance co-founder Frank Burroughs said it is always best to let the patient community speak for itself to most vividly illustrate, as he put it in a recent phone interview, “the plight, the urgency, the vital need for change; that their biggest risk is not some unknown side effect, but the termination of their life.”

That said, Burroughs is realistic that the “FDA isn’t going to favor one drug over another based on a patient advocacy group.” The best thing that patients and their advocates can do to impact the drug approval process, he said, “is make sure the FDA knows they’re being watched by patients and their families and by Congress.”

In mid-March, McNary along with two other DMD mothers were on the Abigail Alliance team that took part in another meeting, this time with FDA commissioner Margaret Hamburg, specifically about how the agency can be more responsive to patient groups, an area it has said repeatedly and publicly it is working on.

“By the end of our meeting,” Jenn McNary said, “we knew we were appreciated; we knew we were listened to. We were given specific suggestions of how to proceed and a direct line of communication to the decision-makers. Here’s my hope: I think they’re going to use Duchenne to show that they’re changing.”

What next?

Max Leclaire rolls on the floor while playing at Saxtons River Elementary School during music class. Before starting the trial for the drug eteplirsen, Max was on the way to becoming wheelchair -bound and starting to lose his basic functions like his brother Austin. Now he can dance around with classmates and act like a normal 11 year-old boy. "Max was slowly stopping being able to walk, and as soon as he's on the drug he's hopping around being more annoying," Austin says. (MADDIE MCGARVEY/FREE PRESS)

Sarepta’s eteplirsen already has received one of the FDA’s expedited pathway designations, Fast Track, which provides extra communication and interaction from the FDA to help move the drug forward. The logistics and realities of filing a successful accelerated approval application involve many steps, however, from a detailed scientific evaluation of the trial study data to whether the FDA believes that a drug company has a solid plan in place to ramp up drug production.

A Sarepta spokesperson confirmed that the drug company’s latest meeting with the FDA took place in March. In a phone interview prior to the meeting, Sarepta CEO and President Chris Garabedian said that the company would use the opportunity to ask specific questions to help inform its decision whether or not to submit an application for accelerated approval. He also said it will take several weeks for the official minutes of that meeting to be issued, which will inform the company’s final decision. Even after that, the exact timing of the drug’s availability will still depend on another meeting to discuss manufacturing details and timeframe.

“The company position,” Garabedian reiterated, “has always been that we’re doing everything we can to expedite approval of eteplirsen working with the FDA so we can get the drug to as many patients as possible who can benefit, as quickly as possible.” If an accelerated approval pathway is successfully pursued, Garabedian said, “the drug could reach patients potentially years earlier than under traditional approval.” However, going for accelerated approval without a strong indication that it will be granted would be bad for all involved, from Sarepta investors to patients, he added.

An FDA spokesperson said the agency would not comment on details regarding any particular drug or company.

Garabedian and his team have worked closely with the DMD community. “This is the most impact that I’ve seen an advocacy group have in the rare disease field since the days of HIV activism,” he said. “They’re sophisticated, they’re organized, they’re pragmatic, and they’re very balanced in their understanding of what the FDA is trying to do and what the drug company is trying to do.”

Back in Saxtons River, the McNarys hold out hope that the news on accelerated approval will be positive and that Austin might have access to the drug before he loses too much more function. “I try not to set deadlines that will hurt if they come and go,” Jenn McNary said. “I did that at the beginning. You can feel discouraged. I can only do what I can do.

“The idea is to save this generation of kids, not to save the kids that aren’t born yet,” Jenn McNary continued. “And the idea is to do it as fast as humanly possible so they don’t lose another single function or we lose another single kid. A kid died today, a 20-year-old kid, a kid that I actually think could have benefited from this drug. That’s very real to me. In a couple years, that could be Austin.”

Meet the McNary Family

More Information: FDA approval for drugs to treat rare diseases

The FDA has placed specific emphasis on providing a variety of priority review designations and pathways to accelerated approval for drugs in development to treat the more than 7,000 diseases classified as rare, which means they affect less than 200,000 people in the U.S., explained Dr. Anne Pariser, associate director for Rare Diseases of the Center for Drug Evaluation and Research within the FDA, in a phone interview. Many of these drugs also qualify for orphan drug status, which qualifies the company developing the drug for tax credits and marketing incentives under the Orphan Drug Act. Eteplirsen, the drug Jenn McNary’s son Max is taking in the clinical trial, has orphan drug status.

“There is tremendous flexibility shown with orphan drugs,” Pariser said. “Patients and families can play a very big role in the development phase, helping make clear what is important to patients ... and what is their risk tolerance.”

The FDA points to a substantial decreases in median length of approvals since 1993, down from 19 months in 1993 to 9.9 months in 2011, according to its FY2012 Innovative Drug Approvals report. However, wrote Stephanie Yao of the FDA Office of Media Affairs in an email, “It’s difficult to definitively say how much time a company saves by working with the FDA during drug development. Each product and disease area is unique.”